Refractive Corneal Implant

ODK · f · Unknown

Classification

FDA Product Code: ODK
Device class: f
Regulation: —
Review panel: OP
Medical specialty: Unknown
Submission type: 6
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure may be potentially deferred.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown